Alzheimer's DiseasePhase 2NCT07721467
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
A Phase 2 study testing Psilocybin and Cognitive Training in people with Alzheimer's Disease, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
Background: Normal aging, as well as dementias such as Alzheimer s disease, can cause changes in the brain that affect memory, attention, and thinking. Researchers want to know if regular mental tasks (cognitive training) can improve brain function in older adults. Read more about this study
- Who is it for?
- Ages 65 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Psilocybin and Cognitive Training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2026to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 120 years
- All sexes
- Healthy volunteers accepted
- Older adult
- Pending Web Eligibility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
Dimitrios Kapogiannis, M.D., 667-391-0063, kapogiannisd@mail.nih.gov
About this study
Official title: Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin (NECTAR) in Aging and Alzheimer's Disease
Background:
Normal aging, as well as dementias such as Alzheimer s disease, can cause changes in the brain that affect memory, attention, and thinking. Researchers want to know if regular mental tasks (cognitive training) can improve brain function in older adults. They also want to know if psilocybin, a compound found in certain mushrooms, can further support improved brain function.
Read more
Objective:
To learn how regular cognitive training, with or without psilocybin, can improve brain health in older adults.
Eligibility:
People aged 65 years and older with mild cognitive impairment or early-stage Alzheimer s disease. Healthy older adults with normal cognition are also needed.
Design:
Participants will be screened. They will have a test of their heart function and an imaging scan. They will have mental health screening and tests of their thinking and memory. They will practice brain-training tasks on a tablet.
Participants will be divided into 2 groups: 1 will have cognitive training plus psilocybin; 1 will have cognitive training only.
Those having cognitive training only will have 5 or 6 clinic visits. They will take the tablet home to practice brain training daily. They will wear a device to measure brain waves as they sleep; they may have 1 overnight stay in the clinic, or they may wear the device at home. Imaging scans and other tests will be repeated at each visit.
Those taking psilocybin will have up to 9 clinic visits. In addition to the visits for cognitive training, they will take 1 psilocybin capsule by mouth 2 weeks apart (the second dose is optional). They will remain in the clinic for 24 hours after each dose.
Read the detailed description
Study Description:
A randomized, open-label, parallel-group clinical trial with two arms aimed at evaluating whether psilocybin enhances the neuroplastic and cognitive benefits of cognitive training in two populations: older adults with normal cognition and individuals with early-stage Alzheimer s disease (AD). Participants in both populations will be randomized to receive either two oral doses of 25 mg of psilocybin, administered two weeks apart, plus cognitive training for four weeks or cognitive training alone for four weeks. The primary outcome will be the change from baseline in a novel Neuroplasticity Composite Score (NPCS) assessed four weeks after the first psilocybin session or the onset of cognitive training. Secondary outcomes include the assessment of safety and tolerability, cognitive performance on TabCAT, RBANS, and autobiographical memory; psychological well-being; quality of life; and sleep. Additional outcomes will include MRI/fMRI/MRS measures of neuroplasticity, brain network connectivity and neurochemistry; EEG during sleep; and plasma and plasma extracellular vesicle (EV)-associated biomarkers of synaptic integrity, serotonergic transmission, neurodegeneration, mitochondrial function, and inflammation. Screening will include clinical and cognitive assessments, assessment of suicidal ideation and behavior, biomarker confirmation of AD pathology, neuroimaging eligibility screening, and laboratory tests for metabolic, hepatic, and renal function. A urine drug screen will confirm the absence of illicit substances, and a urine pregnancy test will be required for female participants of childbearing potential. By simultaneously assessing cognitive and brain function and structure at multiple levels, this study will provide proof-ofconcept for psilocybin s potential to promote neuroplasticity, enhance cognition, improve emotional well-being, and mitigate neurodegenerative processes in aging and AD. Additionally, the inclusion of understudied geriatric populations will address critical gaps in psilocybin s safety and efficacy profile in older adults.
Objectives:
Primary Objective:
-Determine whether psilocybin enhances neuroplasticity four weeks after the first psilocybin session compared to cognitive training alone.
Secondary Objectives:
- Assess the safety and tolerability of psilocybin in cognitively healthy older adults and individuals with early-stage AD.
- Assess whether psilocybin enhances cognitive performance on TabCAT, RBANS and autobiographical memory, compared to cognitive training alone.
- Evaluate whether psilocybin enhances neuroplasticity-related changes on MRI, resting state fMRI, and MRS (i.e., changes in microanatomy, structural \& functional connectivity, neurotransmitter levels) compared to cognitive training alone.
- Evaluate whether psilocybin enhances neuroplasticity-related changes on EEG during sleep (sleep architecture, spectral power) compared to cognitive training alone.
- Investigate whether psilocybin followed by cognitive training changes plasma and plasma EV-associated biomarkers, compared to cognitive training alone, focusing on synaptic, neurodegenerative, mitochondrial, and inflammatory markers.
- Characterize salivary stress-related biomarkers (e.g., cortisol and related hormones) and explore their association with acute psilocybin response and longer-term outcomes, and their longitudinal changes.
- Evaluate changes in psychological well-being (anxiety, depressive symptoms, trauma-related symptoms, alcohol craving/misuse, broader dimensions of well-being such as autonomy, purpose in life, personal growth); overall quality of life; and sleep with psilocybin followed by cognitive training compared to cognitive training alone.
- Assess differences between the first and second psilocybin session.
Endpoints:
Primary Endpoint:
-Change in NPCS four weeks after the first psilocybin session and initiation of cognitive training compared to cognitive training alone.
Secondary Endpoints:
- Safety \& Tolerability: Incidence of adverse events.
- Change in NPCS, four days after the first psilocybin session and initiation of cognitive training, compared to cognitive training alone.
- Cognitive Outcomes: Change in TabCAT Brain Health Assessment (TabCAT-BHA) global composite score and individual task scores, RBANS total score, autobiographical memory performance (Reminiscence Functions Scale, Autobiographical Event Recall Test, DRM Paradigm), and performance in individual cognitive tests with psilocybin followed by cognitive training, in the short- (i.e., four days) and mid-term (i.e., four weeks), compared to cognitive training alone.
- Neuroimaging Outcomes: Changes in MRI, resting state fMRI, and MRS measures, including changes in microstructure and myelin and axonal integrity, BrainAGE, brain network connectivity, and neurotransmitter concentrations with psilocybin followed by cognitive training, compared to cognitive training alone.
- EEG Outcomes: Changes in sleep architecture and quantitative EEG spectral power with psilocybin and cognitive training, compared to cognitive training alone.
- Biomarkers: Changes in plasma and plasma EV-associated markers of synaptic function and neuroplasticity, neurodegeneration, mitochondrial function, and inflammation, with psilocybin and cognitive training, compared to cognitive training alone.
- Salivary Stress Biomarkers: Association of salivary cortisol and related hormones with acute psilocybin response and longer-term outcomes, and their longitudinal changes.
- Psychological and Quality of Life Outcomes: Changes in State- Trait Anxiety Inventory-State (STAI-State), Montgomery(SqrRoot) sberg Depression Rating Scale Self report (MADRS-S), PTSD Checklist for DSM-5 (PCL-5), Penn Alcohol Craving Scale (PACS), National Institutes of Health-Healing Experience of All Life Stressors (NIH-HEALS), Ryff Psychological Well-Being Scales, Neuropsychiatric Inventory Questionnaire (NPI-Q), Quality of Life in Alzheimer s Disease (QOL-AD) Scale, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) with psilocybin followed by cognitive training, compared to cognitive training alone.
- Subjective Effects Questionnaires: Scores on the Mystical Experience Questionnaire (MEQ30), Challenging Experience Questionnaire (CEQ-Challenge), Ego-Dissolution Inventory (EDI), and Drug Effects Questionnaire (DEQ) following each psilocybin session.
- Conditions
- Alzheimer's Disease
- Being tested
- Psilocybin, Cognitive Training
- Keywords
- Aging, Psilocybin, Cognitive Training
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
25 mg orally x 2 (2 weeks apart)
Cognitive TrainingOther
daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| early-stage Alzheimer's Disease (AD) population - cognitive training only | Active comparator | older adults with early-stage AD, 4 weeks of cognitive training alone Receives: Other: Cognitive Training |
| early-stage Alzheimer's Disease (AD) population - cognitive training plus psilocybin | Experimental | older adults with early-stage AD, two oral doses of 25mg of psilocybin, administered two weeks apart, plus cognitive training for four weeks Receives: Drug: Psilocybin; Other: Cognitive Training |
| Normal Cognition population - cognitive training only | Active comparator | Older adults with normal cognition, 4 weeks of cognitive training alone Receives: Other: Cognitive Training |
| Normal Cognition population - cognitive training plus psilocybin | Experimental | Older adults with normal cognition, two oral doses of 25mg of psilocybin, administered two weeks apart, plus cognitive training for four weeks Receives: Drug: Psilocybin; Other: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether psilocybin enhances neuroplasticity (Neuroplasticity Composite Score (NPCS))
two doses, 25 mg each, of psilocybin given two weeks apart plus 4 weeks of cognitive training vs. cognitive training alone.
Measured: 4 weeks
Secondary outcomes (1)
Assess the safety and tolerability of psilocybin in cognitively healthy older adults and individuals with early-stage AD.
two doses, 25 mg each, of psilocybin given two weeks apart plus 4 weeks of cognitive training vs. cognitive training alone.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start11 Nov 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Dimitrios I Kapogiannis, M.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721467
- Sponsor's protocol ID
- 10002693
- Other IDs
- 002693-AG
- Status last verified
- 16 Oct 2026
- First submitted
- 22 Jul 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin (NECTAR) in Aging and Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07721467
- Acronym / sponsor ID
- 10002693
- Conditions
- Alzheimer's Disease
- Keywords
- Aging, Psilocybin, Cognitive Training
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- 11 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Normal aging, as well as dementias such as Alzheimer s disease, can cause changes in the brain that affect memory, attention, and thinking. Researchers want to know if regular mental tasks (cognitive training) can improve brain function in older adults. They also want to know if psilocybin, a compound found in certain mushrooms, can further support improved brain function.
Objective:
To learn how regular cognitive training, with or without psilocybin, can improve brain health in older adults.
Eligibility:
People aged 65 years and older with mild cognitive impairment or early-stage Alzheimer s disease. Healthy older adults with normal cognition are also needed.
Design:
Participants will be screened. They will have a test of their heart function and an imaging scan. They will have mental health screening and tests of their thinking and memory. They will practice brain-training tasks on a tablet.
Participants will be divided into 2 groups: 1 will have cognitive training plus psilocybin; 1 will have cognitive training only.
Those having cognitive training only will have 5 or 6 clinic visits. They will take the tablet home to practice brain training daily. They will wear a device to measure brain waves as they sleep; they may have 1 overnight stay in the clinic, or they may wear the device at home. Imaging scans and other tests will be repeated at each visit.
Those taking psilocybin will have up to 9 clinic visits. In addition to the visits for cognitive training, they will take 1 psilocybin capsule by mouth 2 weeks apart (the second dose is optional). They will remain in the clinic for 24 hours after each dose.
Detailed description
Study Description:
A randomized, open-label, parallel-group clinical trial with two arms aimed at evaluating whether psilocybin enhances the neuroplastic and cognitive benefits of cognitive training in two populations: older adults with normal cognition and individuals with early-stage Alzheimer s disease (AD). Participants in both populations will be randomized to receive either two oral doses of 25 mg of psilocybin, administered two weeks apart, plus cognitive training for four weeks or cognitive training alone for four weeks. The primary outcome will be the change from baseline in a novel Neuroplasticity Composite Score (NPCS) assessed four weeks after the first psilocybin session or the onset of cognitive training. Secondary outcomes include the assessment of safety and tolerability, cognitive performance on TabCAT, RBANS, and autobiographical memory; psychological well-being; quality of life; and sleep. Additional outcomes will include MRI/fMRI/MRS measures of neuroplasticity, brain network connectivity and neurochemistry; EEG during sleep; and plasma and plasma extracellular vesicle (EV)-associated biomarkers of synaptic integrity, serotonergic transmission, neurodegeneration, mitochondrial function, and inflammation. Screening will include clinical and cognitive assessments, assessment of suicidal ideation and behavior, biomarker confirmation of AD pathology, neuroimaging eligibility screening, and laboratory tests for metabolic, hepatic, and renal function. A urine drug screen will confirm the absence of illicit substances, and a urine pregnancy test will be required for female participants of childbearing potential. By simultaneously assessing cognitive and brain function and structure at multiple levels, this study will provide proof-ofconcept for psilocybin s potential to promote neuroplasticity, enhance cognition, improve emotional well-being, and mitigate neurodegenerative processes in aging and AD. Additionally, the inclusion of understudied geriatric populations will address critical gaps in psilocybin s safety and efficacy profile in older adults.
Objectives:
Primary Objective:
-Determine whether psilocybin enhances neuroplasticity four weeks after the first psilocybin session compared to cognitive training alone.
Secondary Objectives:
- Assess the safety and tolerability of psilocybin in cognitively healthy older adults and individuals with early-stage AD.
- Assess whether psilocybin enhances cognitive performance on TabCAT, RBANS and autobiographical memory, compared to cognitive training alone.
- Evaluate whether psilocybin enhances neuroplasticity-related changes on MRI, resting state fMRI, and MRS (i.e., changes in microanatomy, structural \& functional connectivity, neurotransmitter levels) compared to cognitive training alone.
- Evaluate whether psilocybin enhances neuroplasticity-related changes on EEG during sleep (sleep architecture, spectral power) compared to cognitive training alone.
- Investigate whether psilocybin followed by cognitive training changes plasma and plasma EV-associated biomarkers, compared to cognitive training alone, focusing on synaptic, neurodegenerative, mitochondrial, and inflammatory markers.
- Characterize salivary stress-related biomarkers (e.g., cortisol and related hormones) and explore their association with acute psilocybin response and longer-term outcomes, and their longitudinal changes.
- Evaluate changes in psychological well-being (anxiety, depressive symptoms, trauma-related symptoms, alcohol craving/misuse, broader dimensions of well-being such as autonomy, purpose in life, personal growth); overall quality of life; and sleep with psilocybin followed by cognitive training compared to cognitive training alone.
- Assess differences between the first and second psilocybin session.
Endpoints:
Primary Endpoint:
-Change in NPCS four weeks after the first psilocybin session and initiation of cognitive training compared to cognitive training alone.
Secondary Endpoints:
- Safety \& Tolerability: Incidence of adverse events.
- Change in NPCS, four days after the first psilocybin session and initiation of cognitive training, compared to cognitive training alone.
- Cognitive Outcomes: Change in TabCAT Brain Health Assessment (TabCAT-BHA) global composite score and individual task scores, RBANS total score, autobiographical memory performance (Reminiscence Functions Scale, Autobiographical Event Recall Test, DRM Paradigm), and performance in individual cognitive tests with psilocybin followed by cognitive training, in the short- (i.e., four days) and mid-term (i.e., four weeks), compared to cognitive training alone.
- Neuroimaging Outcomes: Changes in MRI, resting state fMRI, and MRS measures, including changes in microstructure and myelin and axonal integrity, BrainAGE, brain network connectivity, and neurotransmitter concentrations with psilocybin followed by cognitive training, compared to cognitive training alone.
- EEG Outcomes: Changes in sleep architecture and quantitative EEG spectral power with psilocybin and cognitive training, compared to cognitive training alone.
- Biomarkers: Changes in plasma and plasma EV-associated markers of synaptic function and neuroplasticity, neurodegeneration, mitochondrial function, and inflammation, with psilocybin and cognitive training, compared to cognitive training alone.
- Salivary Stress Biomarkers: Association of salivary cortisol and related hormones with acute psilocybin response and longer-term outcomes, and their longitudinal changes.
- Psychological and Quality of Life Outcomes: Changes in State- Trait Anxiety Inventory-State (STAI-State), Montgomery(SqrRoot) sberg Depression Rating Scale Self report (MADRS-S), PTSD Checklist for DSM-5 (PCL-5), Penn Alcohol Craving Scale (PACS), National Institutes of Health-Healing Experience of All Life Stressors (NIH-HEALS), Ryff Psychological Well-Being Scales, Neuropsychiatric Inventory Questionnaire (NPI-Q), Quality of Life in Alzheimer s Disease (QOL-AD) Scale, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) with psilocybin followed by cognitive training, compared to cognitive training alone.
- Subjective Effects Questionnaires: Scores on the Mystical Experience Questionnaire (MEQ30), Challenging Experience Questionnaire (CEQ-Challenge), Ego-Dissolution Inventory (EDI), and Drug Effects Questionnaire (DEQ) following each psilocybin session.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| early-stage Alzheimer's Disease (AD) population - cognitive training only | Active comparator | Other: Cognitive Trainingolder adults with early-stage AD, 4 weeks of cognitive training alone |
| early-stage Alzheimer's Disease (AD) population - cognitive training plus psilocybin | Experimental | Drug: Psilocybin, Other: Cognitive Trainingolder adults with early-stage AD, two oral doses of 25mg of psilocybin, administered two weeks apart, plus cognitive training for four weeks |
| Normal Cognition population - cognitive training only | Active comparator | Other: Cognitive TrainingOlder adults with normal cognition, 4 weeks of cognitive training alone |
| Normal Cognition population - cognitive training plus psilocybin | Experimental | Drug: Psilocybin, Other: Cognitive TrainingOlder adults with normal cognition, two oral doses of 25mg of psilocybin, administered two weeks apart, plus cognitive training for four weeks |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin25 mg orally x 2 (2 weeks apart) | Drug | Normal Cognition population - cognitive training plus psilocybin, early-stage Alzheimer's Disease (AD) population - cognitive training plus psilocybin |
| Cognitive Trainingdaily for 4 weeks | Other | Normal Cognition population - cognitive training only, Normal Cognition population - cognitive training plus psilocybin, early-stage Alzheimer's Disease (AD) population - cognitive training only, early-stage Alzheimer's Disease (AD) population - cognitive training plus psilocybin |
Primary outcome
Determine whether psilocybin enhances neuroplasticity (Neuroplasticity Composite Score (NPCS))
Time frame: 4 weeks
two doses, 25 mg each, of psilocybin given two weeks apart plus 4 weeks of cognitive training vs. cognitive training alone.
1 secondary outcome
Assess the safety and tolerability of psilocybin in cognitively healthy older adults and individuals with early-stage AD.
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dimitrios I Kapogiannis, M.D. principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin and Cognitive Training in people with Alzheimer's Disease, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sierra D Kunkosi ((410) 350-3941, sierra.kunkoski@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine whether psilocybin enhances neuroplasticity (Neuroplasticity Composite Score (NPCS)) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.